In a January 5 letter to stockholders, President and CEO Dror Bashan emphasized Protalix’s dual focus for 2026: advancing its proprietary clinical pipeline while leveraging partnered commercial programs to generate profitable growth. The company’s three core objectives are: support Chiesi’s global launch of Elfabrio® for Fabry disease, drive PRX-115 through mid-stage development in uncontrolled gout and accelerate rare renal disease programs such as PRX-119. Bashan highlighted that this balanced approach is designed to limit downside risk from early-stage R&D spending while preserving upside through later-stage value creation.

Protalix reported that its Phase 1 trial of PRX-115, a PEGylated plant-derived uricase for uncontrolled gout, demonstrated rapid and durable urate reductions below target levels (<6 mg/dL) across all cohorts, with effect lasting up to 12 weeks at higher doses and a favorable safety profile. The IND for PRX-115 became effective in October 2025, and the first Phase 2 sites are now fully activated under NCT05745727. In parallel, PRX-119, a long-acting DNase I designed to degrade neutrophil extracellular traps and reduce renal inflammation and fibrosis, remains on track in preclinical studies as Protalix sharpens its rare kidney disease focus.

Protalix’s revenue foundation is anchored by two partnered enzyme replacement therapies. Under its agreement with Chiesi Global Rare Diseases, Elfabrio® launch metrics—treated patient counts and market share in the U.S., EU and additional territories—continue to track to plan following U.S. and EU approvals in May 2023. The global Fabry market is forecasted to reach approximately $3.4 billion by 2030, and management projects Elfabrio could secure 15–20% of that market. Meanwhile, Elelyso® sales via Pfizer and Fundação Oswaldo Cruz deliver steady royalties that underpin operating resilience. An appeal of the EMA’s November 2025 negative opinion on a flexible dosing regimen for Elfabrio is expected in Q1 2026, but the existing bi-weekly label remains unaffected.

Protalix recently announced an RNA-based collaboration with Secarna Pharmaceuticals, leveraging Secarna’s AI-driven OligoCreator® platform to co-develop novel therapeutics for rare renal indications. Looking ahead, management reiterated its pledge to facilitate Chiesi’s commercial performance, advance PRX-115 as a potential best-in-class gout therapy and progress renal programs through innovation and select partnerships. With a profitable partnered business and a purpose-built pipeline targeting high-value unmet needs, Protalix aims to deliver durable growth and maximize long-term shareholder value.